BioRestorative Therapies Lower Back Candidate Shows Decrease In Pain, Increased Function
BioRestorative Therapies Lower Back Candidate Shows Decrease In Pain, Increased Function
The 10 safety run-in subjects reported no serious adverse events (SAEs).BioRestorative Therapies Inc. (NASDAQ:BRTX) revealed on Wednesday new preliminary 26 to 52 week blinded data from the first 10 patients with chronic lumbar disc disease (cLDD) enrolled in the ongoing Phase 2 trial of BRTX-100.
BioRestorative Therapies Inc. (纳斯达克:BRTX) 在周三透露了来自正在进行的BRTX-100第二阶段试验中首批10名慢性腰椎间盘疾病患者（cLDD）新的初步盲法数据，数据时间范围为26到52周。
BRTX-100 is a novel cell-based therapeutic engineered to target body areas with little blood flow.
BRTX-100是一种新型电芯治疗药物，旨在针对血液流动较少的身体部位。
A Phase 2 study is evaluating the safety and efficacy of BRTX-100 in treating cLDD. Up to 99 eligible subjects will be enrolled.
第二阶段研究正在评估BRTX-100在治疗cLDD方面的安全性和有效性。最多将招募99名符合条件的受试者。
The 10 safety run-in subjects reported no serious adverse events (SAEs).
10名安全性预试验受试者报告没有严重不良事件（SAE）。
There was also no dose (40X106 cells) limiting toxicity at 26 to 52 weeks.
在26到52周时，剂量（40X106电芯）没有限制毒性。
The company reported blinded clinical data on the secondary efficacy endpoint of at least a 30% decrease in pain measured on the Visual Analog Scale (VAS) and at least a 30% increase in function based on the Oswestry Disability Index (ODI) at week 52.
该公司报告了关于至少在视觉模拟评分（VAS）上疼痛减少30%和基于Oswestry残疾指数（ODI）功能提高30%的二级有效性终点的盲法临床数据，数据收集时间为第52周。
The blinded preliminary efficacy endpoint data demonstrated:
盲法初步有效性终点数据表明：
- At 26 weeks, 70% of subjects (n=10) and 100% of subjects (n=4) at 52 weeks reported a >30% improvement in VAS versus baseline.
- At 12 and 26 weeks, 70% of subjects (n=10) had a >30% improvement in ODI versus baseline.
- At 52 weeks, 100% of subjects (n=4) had a >30% improvement in ODI versus baseline.
- At 26 weeks, 70% of subjects (n=10) reported a >30% decrease in pain (VAS) and a >30% increase in function (ODI).
- 在26周时，70%的受试者（n=10）和52周时100%的受试者（n=4）报告与基线相比VAS改善超过30%。
- 在12周和26周时，70%的受试者（n=10）在ODI上比基线改善超过30%。
- 在52周时，100%的受试者（n=4）在ODI上比基线改善超过30%。
- 在26周时，70%的受试者（n=10）报告疼痛（VAS）减少超过30%，功能（ODI）提高超过30%。
BRTX Price Action: BRTX stock is down 1.22% at $1.62 at last check Wednesday.
BRTX价格动态：BRTX股票在周三最后检查时下跌1.22%，报$1.62。
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译文内容由第三方软件翻译。